N/A
N=43
Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis
Rib Fractures
Bottom Line
View on ClinicalTrials.gov: NCT05330611 ↗Enrolled (actual)
43
Serious AEs
22.5%
Results posted
Apr 2026
Primary outcome: Primary: Daily Numeric Pain Score — 7.48; 6.47 score on a scale — p=0.2228
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cryoneurolysis of Intercostal Nerves (Device); Standard of Care (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Numeric Pain Score |
7.48; 6.47 | 0.2228 |
| SECONDARY Daily Narcotic Equivalents |
60; 15; 0; 0; 0; 0 | 0.068 |
| SECONDARY Number of Patients With 30-day Mortality |
0; 0 | — |
| SECONDARY Need for ICU Admission |
3; 0 | 0.233 |
| SECONDARY Number of Patients With a 30-day Rib-specific Admission |
0; 0 | — |
| SECONDARY The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores |
3.19; 2.07; 2.19; 1.53; 0.19; 0 | 0.220 |
| SECONDARY The Glasgow Outcome Scale Extended (GOS-E) Score |
1; 0; 8; 5; 1; 2 | 0.784 |
| SECONDARY Short Form (SF-12) Health Survey Scale Summary Scores |
34.28; 32.04; 53.60; 51.74; 40.89; 54.55 | 0.953 |
| SECONDARY Length of Hospital Stay |
4; 3 | 0.066 |
Summary
The purpose of this research study is to examine the effectiveness of using the Iovera Smart Time 190, for ultrasound-guided cryoneurolysis, in trauma patients 18-64 years old with rib fractures that are not candidates for surgical stabilization. This will offer patients the benefits of cryoneurolysis of the intercostal nerves, thereby providing short and long term pain control while their ribs heal.
The Iovera Smart Tip 190 is FDA approved for cryoneurolysis.
Eligibility Criteria
Inclusion Criteria
- Patients 18 to 64 years with any acute rib fracture between rib 3 and rib 9
- Pain score equal to or greater than 5 with deep inspiration
- Presenting and admitted to Stanford Adult Emergency Department, having a trauma consult, and being admitted to the trauma floors of Stanford Healthcare (SHC) for their inpatient stay
Exclusion Criteria
- Radiographic evidence of metastasis to ribs
- Glasgow Coma Scale (GCS) score 1.5, Plt < 100)
- Other factors precluding cryoneurolysis at the attending's discretion
- If only ribs broken are 1, 2 or 10,11,12
- Inability to be positioned for the procedure
- If the patient has the following conditions that the manufacturer of the Iovera device advises AGAINST using the device if present: Cryoglobulinemia, Paroxysmal cold hemoglobinuria, Cold urticaria, Raynaud's disease, open and/or infected wounds at or near the treatment site.
Data sourced from ClinicalTrials.gov (NCT05330611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.